Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which is the highest classification for medical device recalls indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or the death. Per the rubric, FDA Class I recalls are assigned a score of 4 (Severe) or higher.
Plain-English summary
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters (Part Number 1012453-08) due to a defect where the balloon may exhibit difficulty or inability to deflate. The recall covers a total of 39,687 units, including 13,891 units in the United States and 25,796 units distributed worldwide.
The affected devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, balloon dilatation of a coronary artery occlusion, and balloon dilatation of a stent after implantation. The recall includes specific lot numbers: 90731G1, 90921G1, 90808G1, 90928G1, 90826G1, 91003G1, 90906G1, 91017G1, and 91106G1.
Healthcare providers and facilities should check their inventory for the specific part number and lot numbers listed in the recall notice. If the devices are found, they should be removed from service and returned to Abbott Vascular according to the instructions provided by the manufacturer.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoc
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
- Hazard
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 17 recalled by Abbott Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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